Inserter

ABSTRACT

The present invention relates to an inserter for an intrauterine system comprising a handle ( 3 ), and an insertion tube ( 6 ) having a first end and a second end, and being arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube ( 6 ) comprises at least one frame slot for receiving a frame of the intrauterine system. The invention also relates to a kit comprising an inserter according to the present invention and an intrauterine system, wherein the intrauterine system ( 1 ) comprises a therapeutic component ( 1   b ) and a continuous, closed frame ( 1   a ), the therapeutic component ( 1   b ) being connected to the frame ( 1   a ) at least one point, and therapeutic component ( 1   b ) of the intrauterine system ( 1 ) is at least mainly arranged inside the first end of the insertion tube ( 6 ) and the frame ( 1   a ) of the intrauterine system ( 1 ) is at least mainly arranged outside the first end of the insertion tube ( 6 ).

The present invention relates to an inserter for positioning anintrauterine device or an intrauterine system in the uterus as well asto a kit comprising an intrauterine system and an inserter.

BACKGROUND OF THE INVENTION

Various types of inserters have been developed for the positioning ofmechanical and copper wire-containing intrauterine devices (IUDs) aswell as of intrauterine systems having a drug containing cylinder(IUSs). In the following, IUD and IUS can be used interchangeably andwhen one is mentioned, it is to be understood that either of them can beused.

Most common inserters are constructed for introducing the device intothe uterus in a contracted state. These inserters usually comprise aninsertion tube having a relatively narrow diameter and a rounded, bluntend which will pass through the cervical canal easily and will notdamage or injure the fundus upon contact therewith, and a plunger insidethe insertion tube. Prior to insertion the device, whether an IUD or anIUS, is usually retracted into the insertion tube either by means ofstring(s) attached to the device and intended for the removal of thedevice from the uterus, or by pushing the device into the insertion tubeby a plunger with inserters having a special window to adapt the devicein the expanded shape (see for example GB 1 403 393). Then the insertiontube with the device therein is introduced through the cervical canalinto the uterus. When the device is correctly positioned, it is releasedeither by pushing the plunger towards the uterus or by holding theplunger steady and by retracting the insertion tube outwards. Onceexpulsed from the insertion tube within the uterine cavity, the deviceis supposed to resume its original expanded shape.

Simple rod-shaped inserters have been suggested for inserting relativelysmall or sufficiently flexible intrauterine devices in their original,expanded shape by using a push-in technique. With these inserters thecorrect positioning and a secure attachment of an IUS or IUD on theinserter as well as proper handling of the removal strings may bedifficult.

The European patent application EP 1 691 740 relates to an inserter,with which the correct positioning and directional stiffness of thedevice in the inserter prior to and during insertion can be ensured, forinstance, by shaping the forward end of the plunger such that the IUSassumes a specified constant configuration when drawn into the insertiontube. The IUS will thus not be twisted during insertion.

European patent EP 798 999 relates to an inserter, which allows thecorrect positioning of an IUS also in those cases in which the elongatemember of a T-shaped device contains active material, which involves adiameter larger than that of an elongate member of a copper-wire IUD.The inserter comprises a plunger, a handle attached to the plunger, astring for the removal of the IUS, a cleft on the end of the handle tolock the string(s) in such a way that the IUS remains immobile inrelation to the plunger, and an insertion tube around the plunger. TheIUS is drawn into the insertion tube by pushing the tube over the deviceor by pulling on the removal threads whereafter the threads are manuallylocked in the cleft. The relative movement of the plunger and theprotective tube is restricted by a stop member or stop members toascertain that the correct configuration of the IUS is achieved. Thestop members ensure that the front edge of the insertion tube is stoppedin a configuration in which the hemispherical tips of the T-wings remainpartly uncovered by the insertion tube but the wings nevertheless remainpressed against each other. This inserter overcomes many of the problemsencountered with the conventional inserters, but the string(s) stillneed to be manually handled and locked.

Furthermore, document WO 2007/075086 shows an applicator for insertingan IUD, wherein the end of the applicator has two recesses for receivingthe flexible arms of the IUD, and for fixing them during insertion.Document NL 8601570 shows an IUD comprising a rod which one end issecured to a ring of resilient material. The IUD, when inserted, ispositioned on an insertion tube such that the rod is inside the tube andthe ring outside of it.

The inserters described in these documents overcome many of the problemsencountered with the conventional inserters, but the string(s) stillneed to be handled and manually locked. Further, the inserters aredesigned primarily for the insertion of the conventional devices whichare to be inserted in a compressed configuration.

Therefore there is still need for an improved kit comprising anintrauterine system and an inserter.

OBJECT AND SUMMARY OF THE INVENTION

An object of the invention is to provide a simple, easy to use inserterand kit comprising an intrauterine system and an inserter for thepositioning of an intrauterine system in the uterus by solving at leastpartially at least some of the problems mentioned above. An object ofthe invention is particularly to provide an inserter and a kit withwhich, during the insertion process, no manual handling of the stringsas such is needed. A further object of the invention is to provide aninserter having an improved system for locking and releasing the removalstrings of an IUS in the necessary steps during the insertion process. Atypical inserter for an intrauterine system according to the presentinvention comprises a handle and an insertion tube having a first endand a second end, and being arranged in connection with the handle. Theinserter is characterized in that the first end of the insertion tubecomprises at least one frame slot for receiving a frame of theintrauterine system.

A typical kit comprising an inserter and an intrauterine system,according to the present invention, is such that [0011] the inserter isaccording to the present invention, [0012] the intrauterine systemcomprises a therapeutic component and a continuous, closed frame, thetherapeutic component being connected to the frame at at least onepoint, and [0013] the therapeutic component of the intrauterine systemis at least mainly arranged inside the first end of the insertion tubeand the frame of the intrauterine system is at least mainly arrangedoutside the first end of the insertion tube.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 illustrates a general overview of an inserter that is part of akit according to an embodiment of the invention.

FIGS. 2A and 2B illustrate an operating principle of an inserter that ispart of a kit according to an embodiment of the invention.

FIGS. 3A and 3B illustrate a an operating principle of an inserter thatis part of a kit according to another embodiment of the invention.

FIGS. 4A and 4B illustrate a locking means usable in an embodiment ofthe invention.

FIGS. 5A and 5B illustrate a locking means usable in another embodimentof the invention.

FIGS. 6A and 6B illustrate a locking means usable in yet anotherembodiment of the invention.

FIGS. 7A and 7B illustrate a locking means usable in still a furtherembodiment of the invention.

FIGS. 8A and 8B illustrate a locking means usable in a furtherembodiment of the invention.

FIGS. 9A, 9B, 9C and 9D illustrate intrauterine systems and theirpositioning on an inserter according to some embodiments of theinvention.

FIGS. 10A and 10B illustrate some details of FIG. 9B.

DETAILED DESCRIPTION OF THE INVENTION

A typical inserter for an intrauterine system according to the presentinvention comprises a handle and an insertion tube having a first endand a second end, and being arranged in connection with the handle. Theinserter is characterized in that the first end of the insertion tubecomprises at least one frame slot for receiving a frame of theintrauterine system.

The invention therefore provides an easy to use inserter and kitcomprising the device and the inserter, by which only few simple stepsare needed to prepare for the insertion and to securely install andposition an intrauterine system into the uterus.

In the present description and claims, the therapeutic component is acomponent capable of inducing a therapeutic effect, for example byreleasing an active agent such as copper ions or hormones. Moreover, byfirst ends are typically meant the ends that are closer to the uterusduring the insertion of the intrauterine system. Second ends are theends opposite to the first ends. Moreover, the terms IUS or IUD andremoval strings are used when describing the preferred embodiment of thepresent invention, but these are not to be construed as limiting theclaims.

There are at least two different ways of arranging the insertion tube inconnection with the handle. Indeed, according to an embodiment of theinvention, the inserter is further characterised in that [0028] thehandle has a longitudinal opening at its first end, said opening havinga longitudinal axis parallel to the longitudinal axis of the inserter, afirst end and a second end, and the inserter further comprises [0029] amovable slider arranged in said longitudinal opening and having a firstend and a second end, [0030] a plunger attached to the handle, thesecond end of the insertion tube being attached to the slider.

According to another embodiment, the second end of the insertion tube isdirectly attached to the handle.

The longitudinal opening on the handle can also be quite narrow and doesnot need to be symmetrically positioned on the handle and with respectto the longitudinal axis.

A typical kit comprising an inserter and an intrauterine system,according to the present invention, is such that [0034] the inserter isaccording to the present invention, [0035] the intrauterine systemcomprises a therapeutic component and a continuous, closed frame, thetherapeutic component being connected to the frame at at least onepoint, and [0036] the therapeutic component of the intrauterine systemis at least mainly arranged inside the first end of the insertion tubeand the frame of the intrauterine system is at least mainly arrangedoutside the first end of the insertion tube.

In the following, several different embodiments of the presentinvention, both the inserter and the kit, are discussed. The informationgiven applies mutatis mutandis to both the inserter and the kit.

According to another embodiment of the invention the therapeuticcomponent is selected from the group consisting of a reservoir foractive agent, a metallic wire and a combination thereof. For example,the reservoir may essentially consist of an elastomer and an activeagent, or the metal wire can be made of copper.

According to an embodiment of the invention, the reservoir of theintrauterine system essentially consists of an elastomer and an activeagent. The reservoir can be for example as described in WO 2003/017971,U.S. Pat. Nos. 6,056,976, 6,299,027 or WO 00/00550, the contents ofwhich are hereby incorporated by reference.

The elastomer can be for example an elastomer composition comprising asiloxane based elastomer, a thermoplastic polyurethane, a thermoplasticpolyurethane elastomer, ethyl vinyl acetate, a polyolefin-basedelastomer, a silicone containing thermoplastic polyurethane or a mixtureof at least two of these. The reservoir may also be of a core andmembrane-type, wherein both parts are preferably made of an elastomercomposition.

The intrauterine system also preferably comprises strings for removal,location or detection of the system, as well as at least one imageenhancing means for improving the detection and/or location of thesystem.

The image enhancing means can be for example selected from the groupconsisting of

a) an inert metal coating on at least part of the body of theintrauterine system;

b) inert metal inserts, clips, rings or sleeves fixedly positioned onthe body of the intrauterine system;

c) metal or ferromagnetic powder or particles or suitable metal oralkali metal salts mixed during the compounding step in the rawmaterials of the frame, core matrix or membrane of the intrauterinesystem, and

d) a metallic cup, connector, adapter, clamp, sleeve or holder fixed ata suitable position on the frame, which can also be used to anchor orjoin the therapeutic component onto the frame.

According to another embodiment of the invention, the therapeuticcomponent is connected to the frame in at least one point. Moreover, theintrauterine system can be connected to the inserter for example via atleast one connection part. The connection part is preferably designedsuch that it enhances the retention of the device on the inserter priorand during the insertion of the device.

The connection part can be for example a hollow knob, adapted to receivea pin, one of these parts being arranged on the intrauterine system andthe other on the inserter. Another option is to use a traditional balljoint. A person skilled in the art is readily able to find a suitablesolution for this connection part.

Also in view of this, and according to an embodiment of the invention,the first end of the insertion tube comprises at least one connectionslot for receiving the connection part of the intrauterine system.Alternatively, the first end of the plunger may comprise a slot forreceiving the intrauterine system, for example for receiving the secondend of the frame or of the therapeutic component of the intrauterinesystem. The first end of the insertion tube may also comprise twodiagonally symmetrical connection slots for receiving the connectionpart of the intrauterine system. It is naturally possible that there aremore than two connection slots, such as three, four, five or six slots.The connection part then preferably comprises suitable parts fitting tothese connections slots. The connection part can also be made to fit onthe plunger. If a plunger is used, it can be designed to receive thetherapeutic component or the frame.

According to the invention, the first end of the insertion tubecomprises at least one frame slot for receiving the frame of theintrauterine system. The first end of the insertion tube may alsocomprise two diagonally symmetrical frame slots for receiving the frameof the intrauterine system. The number of frame slots can also behigher, such as three, four, five or six. The frame slots can beparallel to the longitudinal axis of the insertion tube or non-parallelto it. The frame slots can for example be straight or slightly curvedwith respect to the outer surface of the insertion tube, in order forallowing the frame to be released. The frame slots are preferably narrowenough to prevent the therapeutic component from slipping out and longenough to allow the movement of the therapeutic component and thestretching/compression of the frame during the insertion step. Theinsertion tube is large enough for containing the therapeutic component.The frame slot(s) together with connection parts assure that theintrauterine system will be securely fitted and in the correctconfiguration during the insertion.

According to an embodiment of the invention, the shape of the frame ofthe device is selected from the group consisting of annular, circular,oval, spiral, toroidal, triangular, polygonal, almond-shape,shield-shape and diamond-shape. The frame is also preferably made of anelastic material, such as an elastomer composition as mentioned above inconnection with the reservoir. The frame may include, for example as acore material, thin metallic wire made for example from a metallicmemory material or other suitable material that is elastic enough forallowing the insertion, i.e. collapsing during the insertion through thecervical canal but returning to its original shape once in place in theuterus.

According to one embodiment of the invention, when the present inserteris in use, the therapeutic component of the intrauterine system ispreferably at least mainly arranged inside the insertion tube and theframe of the intrauterine system is preferably at least mainly arrangedoutside the insertion tube.

According to another embodiment of the invention, the inserter furthercomprises a flange arranged on the insertion tube. This flange can beadjusted to correspond to the depth of the uterus in order to correctlyposition the device during its insertion.

According to one embodiment of the invention, the first end of theopening and the first end of the slider form a first pair of stopmembers, and the second end of the opening and the second end of theslider form a second pair of stop members.

A part of the handle can thus comprise an opening having a first end anda second end and running in the longitudinal direction of the plunger.The opening can have at the first end a channel in which the insertiontube can slide in the longitudinal direction. At the second end, i.e.distal end (away from the uterus) the insertion tube is attached to theslider or to a means which can be used to move the slider and preferablyforms at least a part of the slider. With respect to the startingconfiguration, the front surface of said means and the surface at thefirst end of the opening, the end directed towards the IUS, togetherform the first pair of stop members. To release the IUS after it hasbeen positioned in the uterus the slider and the insertion tube will bepulled backwards past the plunger the distance determined by the secondpair of stop members, formed by the rear surface of the means to movethe slider and the surface at the second end of the opening.

The handle can have many shapes and is designed for easy handling of theinserter even by using only one hand. The plunger attached to the handleis advantageously hollow or has a groove or bore running in the axialdirection thus allowing the string(s) to slide freely in it, without anyrisk of them getting jammed between the plunger and the insertion tube.The first end, i.e. the forward end of the plunger is preferablysuitably shaped to have for example a notch, an indentation, an eyelet,a funnel or a groove to adapt the lower end of the device and to enablethe optimal and secure positioning of the device on the plunger.

The forward parts (parts directed towards the uterus) of the plunger andthe insertion tube can be straight or curved so as to conform to theanatomy of the uterus. Preferably these parts are made from a flexiblematerial in order to avoid perforation of the uterus.

The slider mechanism is preferably inside the handle and comprises atleast one elongated element, which can be moved in the longitudinaldirection of the plunger. According to an embodiment of the inventionthe slider comprises a means to move the slider, which preferably is apart of the slider, and the insertion tube attached to said means.According to another embodiment of the invention the slider comprises atleast two elements, preferably parallel, which are combined on at leastone point by a transversal member. The transversal member may formmeans, for example a knob or switch, by which the slider can be moved.The handle can comprise one or more means to connect the slider elementsand to facilitate the movement of the slider, for example a support, ashoulder, a holder, a saddle, a groove or a slot. The slider preferablycomprises at least one structural element, for example an extension,which is capable to generate the necessary operation of a locking meansto keep the strings immobilized during storage or during preparatorysteps before insertion and/or to release the string(s) when the slideris moved to the backward position.

The inserter according to the present invention may thus also compriselocking means for reversibly locking the intrauterine system in relationto the plunger, said locking means being controllable by the sliderand/or the insertion tube. This means that the locking means can also becontrolled by a part of the slider and/or of the insertion tube, such asan extension of either or both of them. The reversible locking of theintrauterine system can be for example achieved by locking the removalstring or strings of the intrauterine system, in such a way that thedevice remains immobile in relation to the plunger during the necessarysteps prior to and during insertion but can be released after the IUShas correctly been positioned in the uterus. Therefore no manualhandling of the strings as such is needed, which increases security andhygiene.

The locking means is any arrangement which, induced by the movement ofthe slider or of the means to move the slider and the insertion tube,can immobilise the removal string(s) to hold the IUS in a stableposition and/or to release the string(s) after insertion to release theIUS. Particularly, the invention relates to a locking means whichcomprises an object capable of reversibly preventing or allowing themovement of the string(s) by at least partly moving or pivoting from theoriginal position, for example rotating around a shaft or an axle, andvertically or horizontally attached to the handle. The object may haveseveral shapes and may be for example round or rod-shaped, wedge,polygonal or rectangular with rounded or sharp corners. The surface ofthe object preferably comprises one or more extensions having variablesize and shape, for example a knob, a rib or a switch. When the slidermechanism is moving backwards, at a suitable point a part or anextension of the slider or of the insertion tube is pressed against atleast one extension of the object thus changing its orientation enoughrelative to the original position to cause release of the string(s).Preferably the object has a slot or pinhole through which the string(s)run.

The locking means may also comprise at least one counterpart againstwhich the string(s) are pressed by the object and thus reversiblyimmobilized in the locking position. The counterpart has a suitableshape adapted to fit at least some part of the surface of the object. Anextension, or extensions of the object can be used to keep the objectand the counterpart in a fixed configuration until the slider is movedbackwards to release the IUS. The counterpart preferably has a suitabledesign to keep the string(s) in proper direction, for example a slot orpinhole through which the string(s) run. Further, the object and said atleast one counterpart have preferably a suitable length and diameter tofit inside the handle.

According to one embodiment of the invention, the locking means thuscomprises

a main part,

a first extension of the main part having an abutment surface,

a counterpart adapted to form a blocking together with the main part,wherein the locking means is rotatably mounted on the inserter.

According to another embodiment of the invention the main part comprisesan opening or a slot in a diagonal direction through essentially thewhole diameter of the main part, adapted to receive at least one removalstring of the intrauterine system.

The locking means can be for example mounted on the handle of theinserter. According to another embodiment of the invention the openingor slot of the main part is adapted to receive a removal string of theintrauterine system.

According to yet another embodiment of the invention, the locking meanscomprises

a main part,

a first extension of the main part having an abutment surface,

a second extension of the main part having a wedge-like shape,

a counterpart, wherein the second extension is adapted to form ablocking together with the counterpart and the locking means isrotatably mounted on the inserter.

According to one embodiment of the invention, the main part hasessentially the shape of a cylinder, or it is of triangular shape, or ofany other suitable shape.

According to one embodiment of the invention the slider comprises anextension adapted to abut on the abutment surface of the first extensionof the main part of the locking means.

According to one other embodiment of the invention the locking meanscomprises a main part comprising a first extension and a secondextension arranged, in their initial position, to be essentially incontact with each other to from a blocking, wherein the slider, a partof the slider, the insertion tube or a part of the insertion tube isarranged to protrude into the main part of the locking means so as toseparate the first and second extensions from each other.

According to yet one other embodiment of the invention the locking meanscomprises

a first locking part and a second locking part movably mounted on theinserter and arranged, in their initial position, to be essentially incontact with each other to form a blocking, and

a first protrusion and a second protrusion arranged on a locationselected from the group consisting of the inner surface of the insertiontube, the outer surface of the insertion tube, the inner surface of theslider and the outer surface of the slider, wherein the first and secondprotrusions are arranged to move the first and second locking parts whenmoving the slider or the insertion tube.

The locking means could also be welding, gluing, cutting, knot oradhesion. The strings could thus be for example attached to the body ofthe inserter by welding (for example by heating), gluing with glue orattaching with an adhesive agent (such as sticker). The slider or theinsertion tube would then release the attachment when moving to releasethe device. Other options could be a knot or other mechanical hindrance,when the slot provided for the strings is larger in the releasingposition. The slider could also comprise a blade that cuts the stringsloose from the inserter.

It is obvious to a person skilled in the art that, in accordance withthe above description, the locking means can be of any other kind thanthose specifically listed above as well as a combination thereof.

During the preparatory steps the string(s) are locked but they arereleased automatically by the slider, when it is drawn backwards inorder to release the IUS. As compared to previous inserters there is noneed to manually handle the removal strings during the preparatory stepsand during insertion, which eliminates the possibility of user-mademistakes.

The present invention also relates to a use of the kit according to theinvention. Any details and embodiments listed above naturally applymutatis mutandis to the use according to the invention.

The present invention also relates to a method for positioning anintrauterine system in a uterus of a patient, wherein the method uses akit according to the present invention.

The method comprises the steps of

sounding the uterus using a probe, for determining the correct insertiondepth,

introducing the inserter into the uterus of the patient until theintrauterine system is in its correct location,

removing the inserter from the uterus of the patient.

The method advantageously contains, as a second step, setting the flangeto show the correct insertion depth. Depending on the inserter, themethod may also comprise, after the introduction of the inserter intothe uterus, the step of moving the slider towards the second end of theopening until the second end of the opening is in contact with thesecond end of the slider, thus releasing the intrauterine system fromthe inserter.

An example of the method for positioning the intrauterine system isgiven hereafter. To insert the IUS only few steps are needed. To preparefor the insertion the sterile package is carefully opened. The IUS ispositioned at the forward end of the plunger or of the insertion tube inthe expanded configuration. The removal string(s) attached to the deviceare preferably immobilised by the locking means to keep the IUS at asteady and correct position until it is released in the uterus.

The inserter is introduced into the uterus until the IUS is in thecorrect location, which is determined beforehand by using a probe andpreferably shown by the flange set at the correct insertion depth.Depending on the inserter, the slider is then moved towards the secondend of the opening until the second end of the opening is in contactwith the second end of the slider, thus releasing the intrauterinesystem from the inserter. The inserter is then removed and the IUSremains in place. The inserter thus allows easy and secure positioningof an IUS.

DETAILED DESCRIPTION OF THE DRAWING

In the following description, the term slider and the correspondingreference number are used to designate both the slider itself and themeans to move the slider attached to the slider. The term slider is usedfor convenience of reading.

FIG. 1 illustrates a general overview of an inserter according to theinvention. The inserter comprises a handle 3, a plunger 2 attached tothe handle, a slider 5, an insertion tube 6 around the plunger, thesecond end of the insertion tube being attached to the slider or to themeans to move the slider. The inserter also comprises means forreversibly locking the string(s) (not shown) in such a way that the IUSremains immobile in relation to the plunger during the necessary stepsprior to and during insertion, and again for releasing the string(s) andthe IUS after it has been inserted. The inserter further comprises anopening 8 in a part of the handle, a channel 9 in which the insertiontube slides in the longitudinal direction, and a flange 4, which can beadjusted so that its distance from the front end of the intrauterinesystem corresponds to the depth of the uterus.

The part of the handle 3 that is closer to its first end has an opening8 having a first end 8 a and a second end 8 b, which opening runs in thedirection of the plunger 2 and has at its first end a channel 9 in whichthe insertion tube 6 slides in the longitudinal direction. In theoriginal configuration the first end 5 a of the slider 5 abuts the firstend 8 a of the opening 8 of the handle 3. The surface of the second end5 b of the slider 5 and the surface at the second end 8 b of the opening8 together form a pair of stop members. At the second end of the handle,i.e. at the end farther away from the uterus, the insertion tube isattached to the slider 5. After the IUS has been inserted, the sliderand the insertion tube can be moved backwards until the surfaces 5 b and8 b contact each other. The locking means are arranged inside the handle3 and are thus not visible.

FIGS. 2A and 2B illustrate an operating principle of an inserteraccording to an embodiment of the invention.

FIG. 2A shows an inserter and an almond-shaped IUS 1 in a configurationas they are in a sterilized package. The IUS is placed in the first end(i.e. the front end, i.e. the entry into the uterus) of the inserter sothat the drug containing reservoir of the device is inside the insertiontube 6 with the bottom tip of the frame, the reservoir or the loopabutting the end of the plunger (shown with reference number 2 a). Themeans to move the slider 5 is on the basic position, and the removalstring(s) (7, shown in the FIG. 2B) inside the inserter are tightenedand locked by the locking means.

FIG. 2B illustrates the procedure to release the IUS. The device in theconfiguration according to FIG. 2A is introduced into the uterus untilthe IUS is in the correct location, where after the device is releasedfrom the insertion tube. While retaining the inserter stationary, theinsertion tube is retracted towards the handle by moving the slider 5backwards until the surface 5 b of the slider abuts the surface 8 b ofthe opening 8. The distance the slider and the insertion tube can bemoved has been selected to indicate clearly the moment at which the IUShas completely been released from the insertion tube moving towards thehandle.

FIGS. 3A and 3B illustrate another embodiment of the invention, anoperating principle of an inserter which does not have a plunger or aslider. The frame of the IUS is marked with the reference number 1 a,and the therapeutic component with reference number 1 b.

FIGS. 4A and 4B illustrate a locking means according to an embodiment ofthe invention. The locking means are arranged preferably at the insideof the handle 3, on any of the inside surfaces of the handle. Thelocking means are used to immobilise and release the string(s) of theIUS.

FIG. 4A illustrates a locking means according to an embodiment of theinvention comprising a main part 10 having essentially the shape of acylinder and comprising an opening 12 there through in a diagonaldirection. The string(s) 7 of the IUS pass through the opening 12. Themain part 10 is rotatably mounted on the handle, on a shaft or an axle(not shown). The locking means also comprises a counterpart 11, suchthat in the locking position the string(s) are immobilized between thecounterpart and the main part. The counterpart thus has a suitable shapeadapted to fit to a part of the surface of the main part. When theslider is moving backwards, at a suitable point a part or an extensionof the slider is pressed against the extension 10 a of the main part 10thus turning it enough to release the string(s), as shown in FIG. 4B.

FIGS. 5A and 5B illustrate a locking means according to anotherembodiment of the invention. FIG. 5A illustrates an object similar tothe one presented in FIG. 4A, but having a different construction of theextension 10 a.

FIGS. 6A and 6B illustrate a locking means according to yet anotherembodiment of the invention. This is a side view of a cylindricallyshaped locking means, having a main part 13 which comprises twoextensions 13 a and 13 b. The locking means can rotate around a shaft oran axle 14 and is preferably attached to a shorter side of the innersurface of the handle. The locking means also comprises a counterpart 15such that the string(s) 7 are immobilised between the counterpart 15 andthe extension 13 b. The counterpart 15 has a suitable shape adapted tofit to a part of the surface of the extension 13 b. When the slider ismoving backwards, at a suitable point a part or an extension of theslider is pressed against the extension 13 a thus turning it enough torelease the string(s), as shown in FIG. 6B. In this case the handle canalso comprise a groove in which the string(s) run (not shown).

FIGS. 7A and 7B illustrate a locking means according to an embodiment ofthe invention. The locking means 16 comprises two extensions 16 a and 16b to immobilize the strings as shown in FIG. 7A. When the slider 5 andthe insertion tube 6 move backwards the slider and/or the insertion tubeprotrudes into the locking means at least partly to expand the meansenough to separate the extensions and to release the strings, as shownin FIG. 7B.

FIGS. 8A and 8B illustrate a locking means according to a furtherembodiment of the invention. The locking means comprises two parts 17 aand 17 b to immobilize the strings as shown in FIG. 8A, said parts beingable to move or turn from the original position. The slider 5 has twoextensions 18 a and 18 b. When the slider 5 and the insertion tube 6move backwards the slider extensions turn the locking parts 17 a and 17b apart from each other enough to release the strings, as shown in FIG.8B.

FIGS. 9A and 9B illustrate an intrauterine system and its positioning onthe inserter according to an embodiment of the invention. Theintrauterine system has a frame 1 a and a therapeutic component 1 b andit is positioned in the insertion tube 6. The intrauterine system isconnected to the inserter via one connection part 19. The first end ofthe insertion tube 6 comprises one connection slot 20 for receiving theconnection part 19. The therapeutic component is essentially completelyand the frame essentially only partly positioned in a frame slot 21.

FIGS. 9C and 9D illustrate another intrauterine system and itspositioning on the inserter according to another embodiment of theinvention. The intrauterine system has the same parts as in FIGS. 9A and9B. The therapeutic component is essentially completely positionedinside the insertion tube and the frame is essentially completelyoutside the insertion tube.

FIGS. 10A and 10B illustrate some details of FIG. 9B, namely the firstend of the insertion tube 6 and the connection of the intrauterinesystem on the insertion tube.

1. An inserter for an intrauterine system comprising a handle (3), andan insertion tube (6) having a first end and a second end, beingarranged in connection with the handle, and the first end of theinsertion tube (6) comprising at least one frame slot for receiving aframe of the intrauterine system, characterised in that the handle (3)has a longitudinal opening (8) at its first end, said opening (8) havinga longitudinal axis parallel to the longitudinal axis of the inserter, afirst end (8 a) and a second end (8 b), and further comprising a movableslider (5) arranged in said longitudinal opening (8) and having a firstend (5 a) and a second end (5 b), a plunger (2) attached to the handle(3), the second end of the insertion tube being attached to the slider(5).
 2. An inserter according to claim 1, characterized in that thefirst end of the insertion tube (6) comprises at least one connectionslot (20) for receiving a connection part of the intrauterine system. 3.An inserter according to claim 1, characterized in that the first end ofthe plunger (2) comprises a slot for receiving the intrauterine system.4. An inserter according to claim 1, characterized in that the first end(8 a) of the opening (8) and the first end (5 a) of the slider (5) forma first pair of stop members, and the second end (8 b) of the opening(8) and the second end (5 b) of the slider (5) form a second pair ofstop members.
 5. An inserter according to claim 1, characterised in thatit further comprises a flange (4) arranged on the insertion tube (6). 6.An inserter according to claim 1, characterized in that the first end ofthe insertion tube (6) comprises two diagonally symmetrical connectionslots (20) for receiving the connection part (19) of the intrauterinesystem (1).
 7. An inserter according to claim 1, characterized in thatthe first end of the insertion tube (6) comprises two diagonallysymmetrical frame slots for receiving the frame (1 a) of theintrauterine system (1).
 8. An inserter according to claim 1,characterized in that it further comprises locking means for reversiblylocking the intrauterine system in relation to the plunger via a removalstring of the intrauterine system, said locking means being controllableby the slider and/or the insertion tube.
 9. A kit comprising an inserteraccording to claim 1 and an intrauterine system, wherein theintrauterine system (1) comprises a therapeutic component (1 b) and acontinuous, closed frame (1 a), the therapeutic component (1 b) beingconnected to the frame (1 a) at at least one point, and the therapeuticcomponent (1 b) of the intrauterine system (1) is at least mainlyarranged inside the first end of the insertion tube (6) and the frame (1a) of the intrauterine system (1) is at least mainly arranged outsidethe first end of the insertion tube (6).
 10. A kit according to claim 9,characterised in that the therapeutic component (1 b) is selected fromthe group consisting of a reservoir for active agent, a metallic wireand a combination thereof.
 11. A kit according to claim 10,characterised in that the reservoir essentially consists of an elastomerand an active agent.
 12. A kit according to claim 10, characterised inthat the metal wire is made of copper.